Senior Medical Writer

PRA; Deutschland; Vor Ort; EUR 55.000 - 85.000; Vollzeit

Zusammenfassung

Join a leading clinical research organization as a Senior Medical Writer, where you will support a Top-5 pharmaceutical company in producing high-quality regulatory documents. This role demands strong writing skills and a solid background in medical writing to facilitate the complete documentation process. You will be responsible for collaborating with study teams, analyzing data, and ensuring that all documents meet submission standards.

Qualifikationen

• 3-5 years of Medical Writing or relevant pharmaceutical experience.
• Strong writing skills for regulatory documents.
• Proficiency in writing CSRs and Protocols.

Aufgaben

• Produce clinical and regulatory documents collaboratively.
• Analyze data to optimize document composition.
• Facilitate document review for submission readiness.

Kenntnisse

Writing skills

Scientific data interpretation

Ausbildung

Bachelor’s degree

Master’s degree

Jobbeschreibung

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Senior Medical Writer

Join the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

As a Senior Medical Writer, you will support a Top-5 pharma company, helping deliver top-quality regulatory and submission documents. You will be fully embedded with our client while being stably employed by ICON.

Responsibilities:

1. Independently produce clinical and regulatory documents in collaboration with Principal Medical Writers, including Clinical Study Protocols and Clinical Study Reports across Phase 1 to Phase 3 in multiple therapeutic areas.
2. Analyze and interpret data thoroughly to determine the best approach for document composition, applying lean writing strategies.
3. Act as the primary contact for the study team regarding document preparation and timelines, including planning.
4. Facilitate document review to ensure submission readiness and final approval, working directly with QC personnel and publishing specialists.

Minimum Requirements:

• Bachelor’s degree required; Master’s degree preferred.
• 3-5 years of Medical Writing or relevant pharmaceutical experience with scientific and regulatory knowledge.
• Strong writing skills with the ability to translate scientific data into clear, scientifically sound, and well-structured messages.
• Proficiency in independently writing various clinical/regulatory documents (mainly CSRs and Protocols), including leading the creation, coordination, review facilitation, and ensuring submission readiness and approval.